Rapid advances in molecular genetic technology have created an opportunity for development of new, improved tests for diagnosis of human disease. We believe that our new electrochemical technology for measurement of specific DNA sequences will have widespread applications in molecular diagnosis of cancer and genetic disease. In Phase I this company (AndCare) developed enabling technology for gene-probe based electrochemical detection and demonstrated its applicability to detection of cancer and genetic disorders. The technology has advantages over current gene-probe detection methods and can transform methods of molecular diagnostics. In Phase II, AndCare will work toward system improvements and development of assays for specific genetic targets. Representative diagnostic assays that will be demonstrated including: mutations in the breast cancer susceptibility gene BRCA1, a point mutation in the gene encoding Factor V, K-ras tumor DNA in blood plasma, and alternatively spliced mRNAs of the CD44 gene. The expected result of Phase II is the demonstration of the AndCare system for detection and identification of specific genetic disorders with the sensitivity, specificity, accuracy, detection limits and ease of use to achieve targeted performance when used with blood of tissue samples. AndCare pioneered the platform technology that will be used in this project. PROPOSED COMMERCIAL APPLICATION: AndCare's electrochemical gene-probe technology makes possible the development of small instruments for the measurement of gene sequences. The resulting products will provide new assay systems for cancer diagnosis, prognosis or monitoring. Systems for new, innovative diagnostic assays will lead to many new products for genetic diseases and cancer that can address an emerging worldwide market of more than 2 billion dollars/yr.